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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHAP CareSource Leqembi Policy Update | OpenPayer
    Ask Trek AI about this page
    CurrentHAP CareSource MI Coordinated HealthPolicy N/A

    Neurology - Leqembi Intravenous and Leqembi IQLIK Utilization Management Medical Policy

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    This policy governs coverage recommendations for lecanemab-irmb administered as Leqembi intravenous infusion or Leqembi IQLIK subcutaneous injection for Alzheimer's disease. It applies to providers requesting authorization under the payer's prior authorization program.

    Policy Summary
    PayerHAP CareSource MI Coordinated Health
    PolicyNeurology - Leqembi Intravenous and Leqembi IQLIK
    Policy CodePolicy N/A
    Change TypeAddition and revision
    Effective DateN/A
    Last ReviewFeb 5, 2025
    Next Review DateN/A
    Key ActionObtain a recent brain MRI within 1 year before initiating Leqembi treatment and before the fifth, seventh, and fourteenth infusions.
    SourceLink
    POLICY UPDATE CHANGES

    Leqembi IQLIK subcutaneous injection was added to the policy with no recommended authorization criteria.

    The policy name was updated from Neurology - Leqembi to Neurology - Leqembi Intravenous and Leqembi IQLIK.

    2Leqembi formulations addressed
    Not recommended

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage stance
    18 monthsRequired prior IV treatment before IQLIK
    10 mg/kg q2wLeqembi IV initiation regimen
    360 mg weeklyIQLIK maintenance regimen
    3Brain MRI checkpoints

    Leqembi Coverage Criteria

    Leqembi IV and IQLIK not recommended for approval

    Coverage is not recommended in the following situations:

    Not recommended circumstances

    • Alzheimer's disease efficacy concern: Leqembi IV or Leqembi IQLIK is requested for Alzheimer's disease. Due to the lack of clinically significant efficacy data, approval is not recommended.

    • Safety concern

      • The patient has a prior cerebral hemorrhage greater than 1 cm in greatest diameter.
      • The patient has more than four microhemorrhages.
      • The patient has superficial siderosis.
      • The patient has evidence of vasogenic edema.
      • The patient has evidence of cerebral contusion.
      • The patient has an aneurysm.
      • The patient has a vascular malformation.
      • The patient has an infective lesion.
      • The patient has multiple lacunar infarcts.
      • The patient has a stroke involving a major vascular territory.
      • The patient has severe small-vessel or white-matter disease.
      • The patient has symptomatic ARIA-E or radiographically severe asymptomatic ARIA-E, for which continued dosing has not been studied.
    • Unlisted circumstance: The requested circumstance is not listed in the Recommended Authorization Criteria.

      Criteria will be updated as new published data are available.

    Safety has not been evaluated in patients with prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than four microhemorrhages, superficial siderosis, vasogenic edema, cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts, stroke involving a major vascular territory, or severe small-vessel or white-matter disease.

    Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

    The policy does not consider the observed slowing of clinical progression sufficient to demonstrate clinically meaningful benefit and therefore does not recommend approval for Alzheimer's disease.

    Authorization and Monitoring Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization applies to Leqembi IV and Leqembi IQLIK, but the policy provides no automation rules or recommended approval criteria for processing requests.

    • No automation is specified.
    • No recommended authorization criteria are provided.
    Documentation Required

    Baseline and Monitoring Brain MRI

    Obtain a recent brain MRI before initiating Leqembi and use scheduled MRI monitoring to assess for asymptomatic amyloid-related imaging abnormalities (ARIA). Enhanced clinical vigilance is recommended during the first seven doses, particularly during titration.

    • Baseline MRI: brain MRI obtained within 1 year before treatment initiation.
    • Monitoring MRIs: obtain brain MRIs before the fifth, seventh, and 14th infusions.

    Product and Clinical Terms

    Leqembi IQLIK
    FormulationLeqembi IQLIK is a subcutaneous (SC) lecanemab-irmb injection.
    Treatment roleLeqembi IQLIK is indicated only for maintenance treatment.
    Preceding IV treatmentMaintenance treatment with Leqembi IQLIK follows 18 months of Leqembi 10 mg/kg administered intravenously every 2 weeks.
    Amyloid-Related Imaging Abnormalities (ARIA)
    ARIAAmyloid-related imaging abnormalities associated with Leqembi that can be observed on brain MRI.
    ARIA-EAmyloid-related imaging abnormalities-edema, involving edema or vasogenic edema.
    ARIA-H

    Leqembi Clinical Background

    Leqembi is an amyloid beta-directed antibody indicated for Alzheimer's disease in patients at the mild cognitive impairment or mild dementia stage.

    Policy Summary
    PayerHAP CareSource MI Coordinated Health
    PolicyNeurology - Leqembi Intravenous and Leqembi IQLIK
    Policy CodePolicy N/A
    Change TypeAddition and revision
    Effective DateN/A
    Last ReviewFeb 5, 2025
    Next Review DateN/A
    Key ActionObtain a recent brain MRI within 1 year before initiating Leqembi treatment and before the fifth, seventh, and fourteenth infusions.
    SourceLink
    On This Page
    Leqembi Coverage CriteriaAuthorization and Monitoring RequirementsProduct and Clinical TermsLeqembi Clinical Background
  1. MRI findings may include ARIA-E (edema) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis).
    2. Denial Risk

    Cerebrovascular and ARIA Safety Concerns

    Leqembi is associated with cerebrovascular and ARIA safety concerns. The policy states that safety has not been evaluated in patients with specified prior hemorrhagic, vascular, ischemic, or severe small-vessel findings, and experience is limited when dosing continues through ARIA.

    • Safety has not been evaluated with prior cerebral hemorrhage greater than 1 cm, more than four microhemorrhages, superficial siderosis, vasogenic edema, cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts, stroke involving a major vascular territory, or severe small-vessel or white-matter disease.
    • There is no experience continuing treatment through symptomatic ARIA-E or asymptomatic radiographically severe ARIA-E.
    • Experience is limited when treatment continues through asymptomatic radiographically mild-to-moderate ARIA-E, and data are limited for patients with recurrent ARIA-E.
    Denial Risk

    Approval Not Recommended for Insufficient Efficacy

    Coverage approval is not recommended for Leqembi IV or Leqembi IQLIK because the policy finds the available efficacy information insufficient to establish clinically meaningful benefit, while safety concerns have been demonstrated in clinical trials.

    • In the Phase IIb study, the primary ADCOMS endpoint had a 64% probability of being better than placebo with 25% less decline at 12 months, below the prespecified 80% probability threshold.
    • Although CLARITY AD showed a treatment difference of -0.45 on CDR-SB at Week 78, the policy states that the slowing of progression did not achieve clinical significance.
    • The policy recommends no approval in the absence of additional clinical trials supporting clinically meaningful benefit.
    Denial Risk

    No Listed Authorization Criteria

    The policy lists no recommended authorization criteria. Coverage is therefore not recommended for circumstances not listed in the Recommended Authorization Criteria; the criteria may be updated as new published data become available.

    • Recommended Authorization Criteria: None.
    • Leqembi IQLIK approval relied on existing Leqembi IV safety and efficacy information, including an unpublished CLARITY AD open-label extension subgroup analysis and pharmacokinetic/pharmacodynamic modeling.
    • Coverage is not recommended for circumstances outside any future listed authorization criteria.
    Amyloid-related imaging abnormalities-hemosiderin deposition, including microhemorrhage and superficial siderosis.